Quality Assurance Manager

20 hours ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

About Sobi

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Sobi is a specialized biopharmaceutical company dedicated to rare diseases. We turn our research into ground-breaking treatments, making medicine more accessible and opening up possibilities for patients and those caring for them.

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Job Description

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  • Lead and manage Computer System Validation (CSV) to ensure e-compliance of GxP systems.">
  • Oversee Quality Data Stewards, evaluate and approve high-level quality concepts and documents, and support CSV inspections and internal audits.">
  • Define and maintain corporate CSV standards and drive the digital Quality roadmap across the GxP arena.">
  • You will have 5 direct reports located in Sweden and Switzerland. The role reports to our Head of Global GxP Compliance & Quality System, based in Basel, Switzerland.">
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Key Responsibilities

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  2. eCompliance: Oversee GxP system lifecycle management, manage Quality Data Stewards, evaluate and approve high-level quality concepts and documents, and support Computerized System Validation (CSV) inspections and internal audits with follow-up activities and remediation guidance.">
  3. CSV Standards and Implementation: Define, maintain, and serve as the single point of contact (SPOC) for corporate Computerized Systems Compliance (CSV) standards across the company. Enable divisions and business units to implement these global CSV standards. Lead the development and enforcement of these standards.">
  4. Compliance Verification: Implement Sobi CSV standards and verify compliance through periodic reviews, ensuring adherence to current GxP and company requirements. Lead the compliance verification process to maintain high standards.">
  5. Digital Quality Roadmap: Develop and drive the digital Quality roadmap and process quality automation across the GxP arena. Provide strategic leadership in the digital transformation of quality processes.">
  6. Training and Guidance: Provide training and guidance to the team and other stakeholders on CSV standards and eCompliance requirements. Lead the development and delivery of training programs to ensure comprehensive understanding and adherence.">
  7. Regulatory Monitoring: Monitor and analyze global regulatory updates related to GxP and integrate relevant regulatory requirements into the Quality Management System (QMS). Lead the integration of regulatory changes to maintain compliance.">
  8. Continuous Improvement and Leadership: Lead initiatives to enhance GxP compliance processes. Engage with stakeholders to ensure alignment in GxP practices, focusing on the QA digital strategy. Develop and manage a high-performance team, fostering collaboration. Drive continuous improvement and innovation in compliance processes, and develop team skills to meet organizational goals and standards.">
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About You

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We are seeking an individual who demonstrates honesty, transparency, and strong ethical standards in all interactions, ensuring trustworthiness and ethical conduct. You inspire your team with collaborative leadership, fostering cross-functional cooperation and innovation. As we are an entrepreneurial company you adapt quickly to changing environments with resilience. Maintains a keen eye for detail, ensuring accuracy and thoroughness in compliance and quality activities. Possesses strong analytical and problem-solving abilities, while keeping the big picture in mind and addressing issues with a sense of urgency.

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Requirements

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  • Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.">
  • Minimum 10 years of experience in the pharmaceutical industry within Quality systems, manufacturing, R&D, or regulatory affairs, with at least 4 years in a leadership role.">
  • Strong understanding of GxP regulations, including FDA, EMA, and other relevant requirements.">
  • Proven experience in GxP system lifecycle management, quality data stewardship, and defining/implementing CSV standards.">
  • Experience in digitalizing QMS, writing procedural documents, and developing digital quality roadmaps.">
  • Proficiency in performance management, KPIs, and Quality Management Review.">
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Why Work with Us?

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At Sobi, we value work-life balance and emphasize a collaborative and team-oriented environment. Opportunities for professional growth, diversity and inclusion, competitive compensation, and making a positive impact on helping ultra-rare disease patients make us an attractive employer. Join us in shaping the future of healthcare and making a difference in people's lives.



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